The Council just received information about a potentially hazardous situation involving the Emergency Cricothyrotomy kits that were just purchased as part of the recent protocol upgrades within the region. This device is being corrected to prevent a possible reduction in product effectiveness. The Council is in the process of replacing these kits now. Due to a combination of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway), rare instances have been discovered where the cuff balloon wall may become weakened and rendered ineffective. In an effort to eliminate any risk to the end user, we are replacing the endotracheal airways for any kits that may have been exposed to these circumstances. No deaths or injuries have been reported to H&H Medical Corporation or the FDA regarding this issue. Until replacement endotracheal airways are received under this action plan, discontinue use and take steps to remove affected units from further use.

Please assist the Council by checking the lot numbers of the kits that you have on your units and if you find any of the affected lot numbers, please e-mail Kendra Sours at the Council by clicking on her name.